510(k) K250867

Dunamis Screw and Suture Locking System by Dunamis Medical, LLC — Product Code HWC

K250867 is an FDA 510(k) premarket notification submitted by Dunamis Medical, LLC for the device "Dunamis Screw and Suture Locking System". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.